FDA Says Patient Selection is Key to Abiomed Impella RP Safety

The benefits Abiomed's Impella RP System outweigh the risks of the device, but only if it is used for the currently approved indication in appropriately selected patients, according to FDA's latest letter about the device. FDA said the latest interim results indicate a lower survival rate for the subgroup of post-approval study patients who would not have qualified for the premarket clinical studies compared to the premarket clinical study survival rate. The agency reported that the most recent post-approval study report shows 12 out of the 42 patients (28.6%) survived to 30 days post device explant or hospital discharge, or to the start of longer-term therapy. In the premarket studies, the survival rate was 73.3%.  "The primary reason for the difference in survival outcome appears to be patient selection," FDA said in a letter to doctors. For patients who would have met the enrollment criteria for the premarket studies, the survival rate was 64.3% (9 out of 14 patients). For the subgroup of patients who would not have qualified for the premarket studies, the survival rate was 10.7% (3 out of 28 patients). Post-approval study patients who would not have qualified for the premarket clinical studies were more likely to have been in cardiogenic shock for longer than 48 hours, experienced a cardiac arrest, or suffered a pre-implant hypoxic or ischemic neurologic event before getting the Impella RP system implanted compared to the patients who wou...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Cardiovascular Source Type: news

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We present a delayed and atypical presentation for a patient with a cardiac perforation after repair of pectus excavatum who underwent successful repair.
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
We present a case of a 62-year-old man who was in cardiogenic shock. He had a history of coronary artery bypass grafting 4 years previously with LIMA-radial artery Y-grafting to a left dominant coronary circulation. Critical stenoses of the left main coronary and left subclavian arteries was seen at angiography. An occluded abdominal aorta precluded the use of mechanical circulatory support. The patient underwent high-risk stenting of the left subclavian artery with a successful outcome. The case highlights the unresolved issue of screening for subclavian stenoses in patients being considered for revascularization with arterial Y-grafting.
Source: Canadian Journal of Cardiology - Category: Cardiology Source Type: research
AbstractWe recently experienced a case of cardiogenic shock due to influenza-related Takotsubo cardiomyopathy with atrial tachycardia and respiratory distress syndrome. Temporary mechanical circulatory support by IMPELLA 2.5 improved end-organ failure and resulted in cardiac recovery with sinus rhythm conversion.
Source: Journal of Artificial Organs - Category: Transplant Surgery Source Type: research
Abstract BACKGROUND: Acute idiopathic pericarditis (AIP) is frequently accompanied by myocardial involvement (AIPM). Although in acute myocarditis, the myocardial inflammation can lead to life-threatening complications, the outcome of patients with AIPM has been described as good. It remains unclear if a good prognosis of patients with AIPM reflects mild myocardial involvement or good medical management. METHODS: A retrospective analysis of life-threatening complications and life-saving interventions in a cohort of 248 consecutive patients admitted to a single medical center between 2006 and 2017 with AIP (n ...
Source: Cardiology Journal - Category: Cardiology Authors: Tags: Cardiol J Source Type: research
Cardiogenic shock is a dreadful complication of myocardial infarction. Despite widespread use and availability, intra ‐aortic balloon pump (IABP) does not reduce mortality nor improves outcomes. Advanced mechanical circulatory support with IMPELLA system can substantially support hemodynamics and improve short‐term prognosis in patients with myocardial infarction and cardiogenic shock. AbstractCardiogenic shock is a dreadful complication of myocardial infarction. Despite widespread use and availability, intra ‐aortic balloon pump (IABP) does not reduce mortality nor improves outcomes. Advanced mechanical circulatory ...
Source: Clinical Case Reports - Category: General Medicine Authors: Tags: CASE REPORT Source Type: research
We report the case of a patient presenting cardiac tamponade and cardiogenic shock due to spontaneous rupture of the circumflex branch of the left coronary artery, which was successfully isolated by bilateral ligation. PMID: 31204372 [PubMed - as supplied by publisher]
Source: International Heart Journal - Category: Cardiology Tags: Int Heart J Source Type: research
Conditions:   Cardiogenic Shock;   Endothelial Dysfunction Interventions:   Biological: Adrecizumab;   Drug: Placebo Sponsor:   Dr. med. Mahir Karakas Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Although invasively measured blood pressure (invBP) is regarded as a “gold standard” in critically ill cardiac patients, the non-invasive BP is still widely used, at least at the initiation of medical care. Th...
Source: BMC Cardiovascular Disorders - Category: Cardiology Authors: Tags: Research article Source Type: research
This article discusses patient assessment and management with anticoagulation, sedation, ventilation, and nutrition. Complications may occur, including bleeding, hemolysis, infection, acute kidney injury, stroke, left ventricular distention, limb ischemia, and upper body hypoxia. Patients may recover enough myocardial function to be weaned from ECMO or may be transitioned to a ventricular assist device or transplant. Quality of life may be affected by VA ECMO but may be no different than patients with other chronic health issues.
Source: Critical Care Nursing Clinics of North America - Category: Nursing Authors: Source Type: research
Response by Di Vece et al to Letter Regarding Article, "Outcomes Associated With Cardiogenic Shock in Takotsubo Syndrome: Results From the International Takotsubo Registry". Circulation. 2019 Jun 18;139(25):e1044-e1045 Authors: Di Vece D, Citro R, Templin C PMID: 31206329 [PubMed - in process]
Source: Circulation - Category: Cardiology Authors: Tags: Circulation Source Type: research
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